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Mechanical Interference Versus Neural Mobilization on Ulnar Neuropathy Post Cubital Tunnel Syndrome (CTS)

Primary Purpose

Cubital Tunnel Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mechanical interference
Neural mobilization
conventional treatment
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cubital Tunnel Syndrome focused on measuring mechanical interference, neural mobilization, ulnar neuropathy, post cubital syndrome

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The patients were diagnosed and referred by an orthopedist. The patient's age ranged from 20 to 55 years old. Recent NCV for ulnar nerve confirming the diagnosis. Unilateral cubital tunnel syndrome with ulnar neuropathy Exclusion Criteria: Patients with cervical brachialgia. Patients with metabolic diseases such as diabetes, severe thyroid disorders, anemia, and -pregnancy. Hypertensive patients or patients who had a previous hand or elbow surgery. Patients with median nerve involvement in proximal areas such as thoracic outlet syndrome. History of carpal tunnel release surgery. Steroid injection

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Mechanical interference

    Neural mobilization

    conventional treatment

    Arm Description

    the patients will receive mechanical interference and conventional treatment three times a week for four weeks

    the patients will receive neural mobilization and conventional treatment three times a week for four weeks

    the patients will receive conventional treatment only three times a week for four weeks

    Outcomes

    Primary Outcome Measures

    pain intensity
    pain will be measured by visual analogue scale. it is a vertical or horizontal 100mm line graduated by different level of pain, starting from 0 (no pain) till 100 (worst pain).

    Secondary Outcome Measures

    function and severity
    Boston Questionnaire will be used for assessing the function and severity of hand. The questionnaire including two parts, namely the symptom severity scale (SSS) and the functional status scale (FSS), is considered a standard tool to evaluate the patients with CTS. The SSS contains 11 questions on different symptoms of hand and FSS comprises of 5 questions assessing the difficulty in performing selected activities. The response to each question was scored from one (mildest) to five (most severe) points. The overall scores for SSS and FSS were calculated as the score sum of all questions.
    ulnar nerve sensory conduction velocity
    electromyography device will be used for measuring ulnar nerve sensory conduction velocity
    ulnar nerve motor distal latency
    electromyography device will be used for measuring ulnar nerve motor distal latency

    Full Information

    First Posted
    June 24, 2023
    Last Updated
    July 1, 2023
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05931731
    Brief Title
    Mechanical Interference Versus Neural Mobilization on Ulnar Neuropathy Post Cubital Tunnel Syndrome
    Acronym
    CTS
    Official Title
    Efficacy of Mechanical Interference Versus Neural Mobilization on Ulnar Neuropathy Post Cubital Tunnel Syndrome: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 30, 2023 (Anticipated)
    Primary Completion Date
    December 30, 2023 (Anticipated)
    Study Completion Date
    December 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    this study will be conducted to compare between mechanical interference and neural mobilization on ulnar neuropathy post-cubital tunnel syndrome
    Detailed Description
    Ulnar nerve neuropathies are the second most common entrapment neuropathy of the upper extremities after carpal tunnel syndrome. Cubital tunnel syndrome (CTS) is a condition that involves pressure or stretching of the ulnar nerve also known as the "funny bone" nerve, which could cause numbness or tingling in the ring and tiny fingers, pain in the forearm, and hand weakness. The ulnar nerve runs in a groove on the inner side of the elbow. Conservative treatment of cubital tunnel syndrome is recommended for patients with mild and moderate symptoms and without changes in cutaneous sensation or muscle atrophy. In addition, a wide variety of conservative approaches including corticosteroid injections as a minimally invasive technique and splinting and bracing failure were recommended for CTS depending on its severity. Manual therapy techniques are part of the physical therapy treatment of CTS, which are classified into two groups including nerve mobilization and mechanical interface mobilization. The aim of the study was to find which manual therapy method-technique directed to mechanical interface and nerve mobilization-has superior beneficial effects on clinical and electrophysiological findings in the conservative management of patients with CTS. Ninety patients with post-cubital syndrome will be allocated randomly to three groups; the first experimental one will receive mechanical interference, the second experimental will receive neural mobilization and the third one will receive conventional treatment for four weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cubital Tunnel Syndrome
    Keywords
    mechanical interference, neural mobilization, ulnar neuropathy, post cubital syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    mechanical interference and neural mobilization
    Masking
    InvestigatorOutcomes Assessor
    Masking Description
    opaque sealed envelop
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Mechanical interference
    Arm Type
    Experimental
    Arm Description
    the patients will receive mechanical interference and conventional treatment three times a week for four weeks
    Arm Title
    Neural mobilization
    Arm Type
    Experimental
    Arm Description
    the patients will receive neural mobilization and conventional treatment three times a week for four weeks
    Arm Title
    conventional treatment
    Arm Type
    Active Comparator
    Arm Description
    the patients will receive conventional treatment only three times a week for four weeks
    Intervention Type
    Other
    Intervention Name(s)
    Mechanical interference
    Intervention Description
    The patients will receive mechanical interference treatment in the form of five techniques, including wrist distraction (3 sets for 3 minutes), rhythmic and gentle stretching of the transverse carpal ligaments, the release of palmar hand fascia, gliding of the finger flexor tendons (using the oscillatory flexion-extension movement of the metacarpophalangeal joint) and release of the upper forearm muscle and fascia were applied. Manual techniques were performed total of 15 minutes in each session each technique included 3 sets for 3 minutes and conventional treatment
    Intervention Type
    Other
    Intervention Name(s)
    Neural mobilization
    Intervention Description
    the patients will receive neurodynamic mobilizations, including sliding techniques and tensioning techniques which are thought to enhance ulnar nerve gliding and restore neural tissue mobility and conventional treatment
    Intervention Type
    Other
    Intervention Name(s)
    conventional treatment
    Intervention Description
    the patients will receive therapeutic ultrasound (frequency of 1 MHz, intensity of 1 W/cm2, for 5 minutes), transcutaneous electrical nerve stimulation (TENS) (frequency of 80 Hz, pulse duration of 60 μs, at the level of comfortable tingling sensation, for 20 minutes) and therapeutic exercises.
    Primary Outcome Measure Information:
    Title
    pain intensity
    Description
    pain will be measured by visual analogue scale. it is a vertical or horizontal 100mm line graduated by different level of pain, starting from 0 (no pain) till 100 (worst pain).
    Time Frame
    up to four weeks
    Secondary Outcome Measure Information:
    Title
    function and severity
    Description
    Boston Questionnaire will be used for assessing the function and severity of hand. The questionnaire including two parts, namely the symptom severity scale (SSS) and the functional status scale (FSS), is considered a standard tool to evaluate the patients with CTS. The SSS contains 11 questions on different symptoms of hand and FSS comprises of 5 questions assessing the difficulty in performing selected activities. The response to each question was scored from one (mildest) to five (most severe) points. The overall scores for SSS and FSS were calculated as the score sum of all questions.
    Time Frame
    up to four weeks
    Title
    ulnar nerve sensory conduction velocity
    Description
    electromyography device will be used for measuring ulnar nerve sensory conduction velocity
    Time Frame
    up to four weeks
    Title
    ulnar nerve motor distal latency
    Description
    electromyography device will be used for measuring ulnar nerve motor distal latency
    Time Frame
    up to four weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The patients were diagnosed and referred by an orthopedist. The patient's age ranged from 20 to 55 years old. Recent NCV for ulnar nerve confirming the diagnosis. Unilateral cubital tunnel syndrome with ulnar neuropathy Exclusion Criteria: Patients with cervical brachialgia. Patients with metabolic diseases such as diabetes, severe thyroid disorders, anemia, and -pregnancy. Hypertensive patients or patients who had a previous hand or elbow surgery. Patients with median nerve involvement in proximal areas such as thoracic outlet syndrome. History of carpal tunnel release surgery. Steroid injection

    12. IPD Sharing Statement

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    Mechanical Interference Versus Neural Mobilization on Ulnar Neuropathy Post Cubital Tunnel Syndrome

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